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DRV/COBI FDC
DRV/COBI is a fixed-dose combination of darunavir (a protease inhibitor) and cobicistat (a pharmacokinetic booster) that inhibits HIV protease to prevent viral replication.
DRV/COBI is a fixed-dose combination of darunavir (a protease inhibitor) and cobicistat (a pharmacokinetic booster) that inhibits HIV protease to prevent viral replication. Used for HIV-1 infection in treatment-naive and treatment-experienced patients.
At a glance
| Generic name | DRV/COBI FDC |
|---|---|
| Also known as | TMC114/JNJ-48763364 |
| Sponsor | Janssen Research & Development, LLC |
| Drug class | Protease inhibitor with pharmacokinetic booster |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Darunavir binds to and inhibits HIV protease, preventing the cleavage of viral polyproteins necessary for infectious particle maturation. Cobicistat is a cytochrome P450 inhibitor that boosts darunavir plasma concentrations by inhibiting its metabolism, allowing for lower and less frequent dosing while maintaining therapeutic levels. Together, they reduce viral load in HIV-infected patients.
Approved indications
- HIV-1 infection in treatment-naive and treatment-experienced patients
Common side effects
- Diarrhea
- Nausea
- Headache
- Rash
- Elevated liver enzymes
Key clinical trials
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- A Study to Evaluate the Pharmacokinetics (PK) of Darunavir (DRV) and Cobicistat (COBI) After a Single Oral Administration of Darunavir/Cobicistat Fixed-Dose Combination in Healthy Japanese Adult Participants (PHASE4)
- A Study to Evaluate the Efficacy and Safety of (D/C/F/TAF) Once Daily Fixed Dose Combination (FDC) Regimen in Newly Diagnosed, Antiretroviral Treatment-naive Human Immunodeficiency Virus Type 1 (HIV-1) Infected Participants Receiving Care in a Test and Treat Model of Care (PHASE3)
- A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants (PHASE1)
- A Study of Darunavir in the Presence of Cobicistat When Administered as a Fixed Dose Combination Under Fed Conditions (PHASE1)
- A Study in Healthy Participants to Assess the Effect of Darunavir, Emtricitabine, and Tenofovir Alafenamide in the Presence of Cobicistat as Fixed Dose Combination (Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide) Compared With Co-administration of the Separate Agents (PHASE1)
- Study to Evaluate the Relative Bioavailability of Fixed-dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) as a Whole Tablet, as a Split Tablet, and as Crushed Tablet in Healthy Adult Participants (PHASE1)
- A Study of Darunavir in Combination With Cobicistat or Ritonavir, and Dabigatran Etexilate in Healthy Participants (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DRV/COBI FDC CI brief — competitive landscape report
- DRV/COBI FDC updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI